Charlotte’s Web: CBD product moves to Phase 2 trial for autism treatment
LOUISVILLE — The U.S. Food and Drug Administration recently wrapped up a review for the first phase of a clinical trial for a CBD product that Louisville-based CBD company Charlotte’s Web Holdings Inc. (TSX: CWEB) believes could be effective in treating symptoms of autism spectrum disorder.
The botanical pharmaceutical candidate, AJA001 Oral Solution, was developed by DeFloria LLC, a joint venture launched in mid-2023 with CW, AJNA Biosciences PBC and British American Tobacco PLC.
DeFloria will now proceed with its FDA Phase 2 clinical trial.
“Progressing to Phase 2 of an (Investigational New Drug) study with the FDA marks an important milestone in the development of our proprietary hemp genetics as regulated medicine,” Charlotte’s Web CEO Bill Morachnick said in a prepared statement. “By leveraging our deep expertise in hemp cultivation and proprietary formulations, we are reinforcing and extending our leadership in hemp wellness from the consumer sector into the regulated medical sector. A safe and effective botanical treatment for autism spectrum disorder would be a medical asset that could provide immense value to millions of families and Charlotte’s Web.”
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The U.S. Food and Drug Administration recently wrapped up a review for the first phase of a clinical trial for a CBD product that Louisville-based CBD company Charlotte’s Web Holdings Inc. believes could be effective in treating symptoms of autism spectrum disorder.
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